Earn Your ISO 13485:2016 Certification

If you work in the startup MedTech industry, you know one of the hardest obstacles to overcome is making sure your medical device is compliant with the rigorous standards set by different organizations. This includes the ISO 13485:2016 standard, which specifies the appropriate quality management system requirements needed for medical devices.

By having your device and QMS certified, you can confidently demonstrate your medical product meets the rigorous requirements for safety and performance for consumers, suppliers, and more.

To learn more about how Cannon Quality Group can help your organization prepare for its ISO 13485:2016 certification, reach out to us today.

What is the ISO 13485 Standard?

ISO 13485 is an internationally recognized standard for assessing a medical device’s quality management system. It’s been adopted from the ISO 9001 QMS standard series and is the world’s most popular standard that has been modified to specifically encompass medical devices.

By being ISO compliant, your medical product satisfies requirements that are upheld throughout the industry, which can offer several benefits, including:

  • Increased market access – By earning the ISO 13485 QMS certification, you can instill confidence in business partners, potential investors, and foreign markets.
  • A focus on safety and performance – This is the most widely respected standard for quality management systems, meaning a compliant medical device abides by safe design, production, and installation procedures and records. Risk analysis continues to be a key aspect of the standard throughout the product lifecycle.
  • Additional insights on how to improve processes – When your quality management system is graded against the top standard in the industry, you’ll be able to identify areas for improvement and ways to increase efficiency.

*It’s important to note if your medical device has been certified to ISO 13485:2003, you are required to transition to the updated 2016 versions by March of 2019.*

To ensure your device remains compliant, contact Cannon Quality Group today, or continue reading about our services below.

Our ISO 13485 Training & Preparation Services

Whether you are new to the standard or need to transition from the previous standards established in 2003 or 2012, Cannon Quality Group is available to help your organization prepare for their medical device QMS certification.

We provide gap assessments and audits to help ensure your medical devices’ quality systems are ISO 13485 compliant. We do this by assessing several factors of your current quality systems, including:

  • Document control
  • Management responsibility
  • Resource management
  • Design control
  • Risk management
  • Production control
  • Complaint handling processes
  • And more

To learn more about our ISO 13485:2016 preparation and assessment services, contact us online today.

CE Mark Certification for Medical Devices

ISO 13485 also acts as the QMS standard accepted under European regulations for earning the CE mark on medical devices. CE marking represents the manufacturer’s claim that their product is compliant with the appropriate European Medical Device Directives. It is legally required for medical products to be sold in the European Union.

If your medical device is expanding into the European markets and you need the CE mark, you need to start with transitioning or becoming ISO 13485 certified.

Choose Cannon Quality Group for ISO 13485 Assessments & Audits

It’s never been easier to prepare your medical device for ISO 13485 certification. Cannon Quality Group offers years of experience in the medical device industry, qualified auditors, and the flexibility to have your product ready for any deadline.

In addition to assessments and audits for various organizations, Cannon Quality Group also offers the Founders Club program. Membership provides MedTech entrepreneurs with access to a fully equipped medical device QMS testing facility. Our shared space facility offers a Class 7 Controlled Environment Room and other amenities.

To learn more about our Founders Club and how you can become a member, contact Cannon Quality Group online today.

Testimonials

"Look what you have done!  Profusa has a functional QS thanks in large part to you. The GMED auditor has conducted over 700 audits and said we have an extremely good QS and a lot of that credit goes to you… I just wanted to let you know that Profusa…"

-David Hesting/QA Director, Profusa, Inc.

"My Manager reviewed and approved this validation, and he called me to say it would be the gold standard for spreadsheet validations for all Nordson Medical D&D sites from this point forward!"

-Kim Trottier/Quality Information Systems Manager, Nordson Medical

"Our notified body commented that he was impressed with the focus and professionalism of the Emboline team during a recent audit. This is largely a credit to the Cannon Quality Group team. Your team, as always, was extremely organized, well-prepared and professional. Thank you!"

-Scott Russell/President and CEO at Emboline, Inc.

"Everything about the audit process including scheduling, the audit itself, and results & follow-up were seamless and enabled LamaMed Solutions, Inc. to fulfill its requirements for Internal Audit and assessment of QMS conformance with ISO 13485:2016 in advance of our Notified Body audit."

-Lloyd Griese/Quality and Regulatory Consultant, LamaMed Solutions, Inc.

"Our SVP of QA/RA performs mock-FDA audits across all our global facilities. So it was huge compliment for us when, after reviewing all aspects of a software validation authored by Cannon Quality Group, he said it was as good a validation as he had ever seen."

-Ron Koronkowski/Director of Quality & Regulatory, Vention Medical, Inc.

"Cannon Quality Group's staff was highly engaged and responsive to our needs. They were easy to work with and provided a high-quality work product."

-Caroline Jewett/Consultant for PvP Biotech

"It was by far the best QSR/GMP training – high caliber content and engaging delivery."

-Robert Angelopoulos/Sr. Engineering Manager, Powervision, Inc.

"Don’t stress. Call Cannon Quality Group for great project support."

-David Freed/Sr. Quality Director, AcelRx Pharmaceuticals, Inc.

"My 3rd party ISO 13485:2016 audit was extremely beneficial to my company. The auditor was very knowledgeable about the standard and current trends that notified bodies are looking for."

-Tom Mason/Director QA, Vactronix Scientific

"When strategic partners were doing due diligence, I think they expected to find an empty drawer where the Quality Management System would be. We started showing them the procedures and design files that Cannon Quality Group helped us establish, and they were pleasantly surprised to get just what they wanted…The ability of…"

-Don Bogue/President/CEO, Compact Imaging

"Our [CQG] auditor provided findings with value-based explanations and implementation ideas."

-Kyle Dion/Quality Specialist, BlueLine Sterilization Services

"CQG has been with my organization from the nascent stages of our QMS.  Their team of experts coached us on the ISO standards, provided training classes, furnished sample QMS documentation, and were always quick to respond to our endless questions.  Most importantly they were present at our crucial certification and customer audits. …"

-Kathleen Perry/Twist Biosciences

"Working with Cannon was a pleasure. They helped us create our first formalized Quality Management System with just the right balance of rigor, detail-orientation, and practicality. I would definitely work with Cannon again in the future on quality management projects."

-Gideon Wald/CTO Welkin Health

"JenaValve would like to extend a very appreciated “Thank You” to the whole Cannon Group team in supporting us, JenaValve, through the quality system improvements and associated activities. Your organization has been exceptional in supporting the chaotic schedule and the Cannon Group team members have performed above and beyond the…"

-Peter Wulff/CFO JenaValve

"Your team is great, love the maturity level. Great respect from Quality & Regulatory."

-Mark Adler/Senior Director of R&D JenaValve

"CQG has really shattered my preconceptions of what contracted support can do for a quality system. They are true professionals from the advice they provide, work they produce, and the integrity of actions. From complicated design control issues, to Process Validation, to Doc Control, they have been a huge resource…"

-David Hesting/QA Director, Profusa, Inc.

"Amy has done an amazing job here and we appreciate all her help. Communication with everyone/doc control is good/responsive, and we especially appreciate the quick turnaround on hot DCO’s – they find everything."

-Bijesh Chandran/VP of Quality, R2 Dermatology

"Cannon Quality Group is an absolute pleasure. For our startup, CQG made QSR development and compliance enjoyable and easy. Their unique style and system has allowed us to work at the fast pace required by the market, while still maintaining regulatory compliance."

-Andrew Hosford/Director of Engineering, Gauss Surgical

"Our startup was working with a skeleton quality system and struggling to apply QSR standards, when we brought in the Cannon Quality Group. They overhauled and sharpened our quality system so that it complied with the QSR, in only a few months, which allowed us to have a flawless audit.…"

-CQG client/

"When a key employee quit just as the load on my QA group exploded because of a clinical build, CQG stepped in immediately with the resources we needed to keep us going. I hope nothing like this ever happens to us again but, if it does, I’ll know exactly whom…"

-Ari Zak/Sr. VP, Clinical, Regulatory & Quality and Corporate Counsel, PowerVision

"Prior to CQG, our startup worked with another company which made quality slow, very expensive, and highly frustrating. Comparatively, CQG has been a game changer for our company. They have made QSR development and compliance enjoyable and easy, which has allowed us to work at the fast pace required by…"

-CQG Client/

"Kudos to the Cannon Quality Group for helping us get through our FDA audit with zero 483s and just a few CAPAs.Their expertise in quickly turning our bare bones QMS into a robust system is exactly what was needed."

-Shaun R. Bagai/CEO – RenovoRx, Inc.

"Pete is awesome, I appreciate the help he provides to our team and his assistance in various quality needs."

-Kityee Au-Yeung/Profusa

"As a new Quality Director at a young start-up company, I am happy to leave a recommendation for Cannon Quality Group. Cannon Quality Group has an innovative and efficient process in place to bring a working Quality System to a start-up company in a short amount of time. Cannon retains…"

-Delane Dale/Quality Director – BioInspire Technologies
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